Investigation of PICOPREP and PEG-ELS for Bowel Preparation for Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01356407
First received: May 18, 2011
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its effectiveness, tolerability and safety.


Condition Intervention Phase
Colonoscopy
Drug: PICOPREP
Drug: PEG-ELS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Single-blind Clinical Study of the Efficacy and Safety of PICOPREP and Polyethylene Glycol-electrolyte 4000 Powder for Oral Solution (PEG-ELS) for the Bowel Preparation Prior Colonoscopy

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation [ Time Frame: day 2 ] [ Designated as safety issue: No ]
    The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 ('excellent' visibility) to 4 ('inadequate' visibility); The component scores for each of the colon segment are added together, along with an overall 'fluid' score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel)


Secondary Outcome Measures:
  • Patient Response to Acceptability and Tolerability Questionnaire [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    On the day of the procedure, but before colonoscopy or any sedation for colonoscopy, subjects were asked to complete a standardised questionnaire regarding whether or not complete the IMP (yes or no), ease of taking IMP (rating from 1 point(very easy) to 5 point (very difficult)), degree of acceptability to study med (rating from 1 point (excellent) to 5 point (bad)), palatability of IMP (rating from 1 point (excellent) to 5 point (bad)) and tolerability (5 adverse reactions including abdominal bloating, spasms, nausea, vomiting and general malaise which were generally reported in bowel preparation with rating according to intensity from 1 point (None) to 4 point (Severe)).

  • Ottawa Scale Score by Colon Segment [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    Mean Ottawa Scale scores, and score categories (from 'excellent' to 'bad'), are summarised by colon segment together with the overall fluid content score

  • Percentage of Successful Completion of Colonoscopy [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve)

  • Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score) [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    At colonoscopy, bowel preparations were rated by the treatment-blinded endoscopist, as being of an overall quality "adequate for clinical diagnostic purposes" (Y/N). The total Ottawa Scale scores was correlated with 'adequate' or 'inadequate' quality of bowel preparation for clinical diagnostic purposes

  • Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation


Enrollment: 300
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PICOPREP
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy.
Drug: PICOPREP
Active Comparator: PEG-ELS
PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
Drug: PEG-ELS

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have signed the informed consent form and have been verbally explained the details of the trial and treatment procedures
  • Chinese citizen
  • Males or females aged between 18 and 70 years inclusive
  • Patients scheduled for colonoscopy
  • Patients who are able to observe instructions given during the study, and are able to complete the entire study procedure

Exclusion Criteria:

  • Those pregnant, breastfeeding, or with the intention of becoming pregnant, or fertile women who are not on effective birth control
  • Taking concomitant lithium
  • Allergy to any ingredient in the study medication
  • History of gastrointestinal diseases (active ulcers, gastric outlet obstruction, gastric retention, intestinal obstruction)
  • Colon diseases (toxic megacolon, toxic colitis, idiopathic intestinal pseudo-obstruction, gastric retention, intestinal obstruction, lazy bowel syndrome) at screening
  • Active (acute/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
  • Acute abdominal symptoms (acute intestinal obstruction, intestinal perforation, diverticulitis or appendicitis)
  • Ascites
  • History of surgery in upper gastrointestinal tract (gastrectomy, gastric banding, gastric bypass surgery)
  • History of colorectal surgery (excluding appendectomy, hemorrhoidectomy and endoscopic surgery)
  • Uncontrolled angina and/or myocardial infarction, congestive heart failure, or uncontrolled hypertension within 3 months prior randomisation
  • Severe liver damage
  • Kidney function impairment
  • Diabetics currently on insulin treatment
  • Having participated in any other clinical trial during the 3 month prior recruitment
  • Patients who are unable to act in a legal capacity, unable to meet or perform study requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356407

Locations
China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
Drum Tower Hospital
Nanjing, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Changhai Hospital, The Second Military Medical University
Shanghai, China
Huazhong Technological University Tongji Medical College Affiliated Union Hospital
Wuhan, China
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01356407     History of Changes
Other Study ID Numbers: FE999169 CS02
Study First Received: May 18, 2011
Results First Received: September 19, 2012
Last Updated: December 17, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Picosulfate sodium
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014